Product Classification

• Device: discs, elution
• Regulation Description: Antimicrobial susceptibility test disc.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: LTX
• Submission Type: 510(k)
• Regulation Number: 866.1620
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• CLSI M27-A3 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts
• CLSI M6-A2 Protocols for Evaluating Dehydrated Mueller-Hinton Agar; Approved Standard - Second Edition
• CLSI M27-S3 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Third Informational Supplement
• CLSI M02-A11 Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard - Eleventh Edition
• CLSI M23-A3 Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters; Approved Guideline - Third Edition
• CLSI M44-A2 Method for Antifungal Disk Diffusion Suceptibility Testing of Yeast; Approved Guideline-Second Edition
• CLSI M44-S3 Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Third Informational Supplement
• CLSI M45-A2 Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline - Second Edition

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.